Freda Birrell, SANE Vax, letter to Committee for Medicinal Products for Human Use regarding Gardasil contamination

Dear Mr Chairman and Vice-Chairman of the CHMP Committee

I am sending the undernoted to all the members of your Committee

The two Press Releases, the one attached above Sane Vax Inc announces the discovery of Viral HPV DNA Contaminant in Gardasil and the following link to Sane Vax Inc discovers potential biohazard contamination in Merck’s Gardasil HPV 4 Vaccine  have to both be read to be believed.

By accident and not by design, information was sent to Sane Vax Inc from a mother in Canada who advised us that her daughter was found to have HPV DNA in her blood 2 Years Post-Vaccination with Gardasil. This was verified by Dr Sin Hang Lee, Pathologist at the Milford Hospital Pathology Laboratory who found no reason to question the local laboratory’s findings.

As it was regarded that this discovery was ‘not normal’ it was decided to analyse a vial of Gardasil. This sample tested positive for recombinant (genetically engineered) viral HPV-11 and viral HPV-18 residues, both of which were firmly attached to the aluminium adjuvant. To make certain that this analysis could be replicated it was decided to obtain other vials, with different lots numbers from various countries around the world. The Gardasil vials with different lot numbers were from New Zealand, Australia, Spain, Poland, France and three states in the U.S. 100% of the samples tested positive for the presence of the genetically modified HPV DNA and the lots tested came from four separate manufacturing facilities.

As indicated above this discovery was by accident and not by design. However, it raises many serious issues which now have to be dealt with by our respective governments in London, in Edinburgh and by the European Parliament. We have been advised by the JCVI, by the European Parliament, by the FDA and by Merck that the HPV vaccines do not contain any viral DNA. This is recorded in links 1, 2 and 3 below and is the official wording from these organisations.

There are now many serious questions which have to be raised regarding this discovery:

  • What action do the UK Government, Scottish Parliament and European Parliament intend to take on this matter?
  • Gardasil is licensed in the UK and comes under the safety umbrella of our Government’s Agencies; Cervarix has been administered in our schools since 2008 (though there is speculation that it will be replaced in the UK by Gardasil) and it is imperative that the same type of analysis has to be carried out to ensure the safety of Cervarix;
  • In the light of what has been discovered nothing can be taken for granted;
  • How many adolescents who have suffered adverse reactions post Gardasil vaccination have HPV DNA in their blood?
  • What are the medical ramifications if HPV DNA should remain in the blood stream for an extended period of time?
  • Is the aluminium adjuvant a carrier for the HPV DNA?
  • What happens if genetically engineered DNA enters a human host cell?
  • Will it mutate the host cell leading towards cancer and other autoimmune disorders?
  • The Medical profession and consumers need to have these questions answered NOW because of the new programme which starts again this September; otherwise serious repercussions could arise if no action is taken;
  • Will proper checks be carried out on Cervarix to ensure that this vaccine does not contain any contaminations bearing in mind it is also a genetically modified vaccine produced by similar manufacturing techniques?
  • Many reports and correspondence have been sent to the UK and Scottish governments informing them of girls who have become seriously ill after vaccination with Cervarix, very similar symptoms to girls who became ill after Gardasil; could these now come back to haunt them if this information is not taken seriously and proper investigations carried out?

 Freda Birrell

East Lothian – Scotland

Secretary Sane Vax Inc – www.sanevax.org

References:

http://www.parliament.uk/deposits/depositedpapers/2011/DEP2011-0706.pdf 1

(end of page 1 and beginning of page 2):

HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.

This is a reference to both Gardasil and Cervarix – Joint Committee on Vaccination and Immunisation

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000721/WC500024632.pdf 2

See 5. Pharmacological Properties

5.1 Pharmacodynamic properties

….. Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. This is a reference to Cervarix, European Medicines Agency

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM231522.pdf 3

Page 12, 3.2

3.2 GARDASIL®- The Quadrivalent HPV (Types 6, 11, 16, 18) Vaccine

…. GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.

Explanation of the word ‘Viral’

Viral is any DNA (whole or partial) that originally came from a virus, in this case the HPV virus, and that could include natural DNA, wild DNA or genetically engineered DNA

The European Medicine agency responded with the following email:

Dear Ms Birrell,

Please find herewith attached the response to your request.

Kind Regards,

Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

info@ema.europa.eu
http://www.ema.europa.eu

Frequently Asked Questions (FAQs) have now been published on the Agency’s website. It comprises answers to the most commonly asked questions submitted to the EMA. You are invited to consult it here: (see attachment below)

Read the reply from Dr. Abadie, Chairman CHMP, here.

Read the EMA adopted response to SANE Vax concerns here. (online version)

Read SANE Vax response to the EMA here.

 

Reply from the Department of Health:

Our ref: DE00000645764

Dear Mrs Birrell,

Thank you for your correspondence of 19 September to the ministers of the Department of Health about Gardasil.  I have been asked to reply.

The Department is aware that this issue was recently considered by the European Committee for Medicinal Products for Human Use (CHMP) and its Biologics Working Party (BWP) at their September meetings.

The CHMP takes very seriously any potential contamination issue and has considered all the available evidence in relation to the statements made about Gardasil in relation to HPV DNA.

The CHMP concluded that the presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients.  The current benefit-risk balance of Gardasil was not considered to be affected by this information and Gardasil is considered to remain safe and effective.

On 23 September, the European Medicines Agency posted the CHMP’s response to the concerns raised by Sane Vax on its website, which can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112851.pdf.

As with all vaccines and medicines, any emerging evidence relating to possible risks associated with the vaccine is carefully reviewed and, if appropriate, regulatory action is taken.

I hope this reply is helpful.

Yours sincerely,
Sarah Walker
Customer Service Centre
Department of Health

Freda Birrell: To UK Parliament’s Health Committee, HPV Vaccine Concerns

10 June 2011, the following letter was sent to various members of the UK Parliament’s Health Committee:

 

Subject: HPV Vaccines Cervarix and Gardasil – for the attention of the Health Committee

For the attention of the Health Committee

Dear Members

I would appreciate it if consideration could be given to the undernoted points relating to the HPV vaccination programme in the UK.

The first paper above was prepared by myself as I had been asked a question by a politician ‘would I be happy if Cervarix was removed from the market’? I replied to this above but also answered the question I was not asked ‘would I be happy if Gardasil replaced Cervarix as the main HPV vaccine in the UK’? I believe the above provides information on both of these vaccines but more importantly on the HPV Gardasil. There has been a lot of speculation in the press of late that consideration is being given to replacing Cervarix with Gardasil in the UK and I wish to draw your attention to the dangers of Gardasil. The information I have provided has been taken from the VAERS Reporting System (Vaccine Adverse Events Reporting System). Please note as of April 2011, 96 deaths have been reported following vaccination, including 2 boys and 21,984 serious adverse effects. It is recognised that this represents only between 1% and 10% of those victims who file reports to VAERS, therefore the true figures could be astronomical. Young healthy girls/women have died suddenly after vaccination with Gardasil and in some cases their cause of death cannot be determined. We hear every week from mothers whose daughters were ill but who did not associate their illnesses with the vaccination until they realised that their daughters’ symptoms were being experienced by so many others. This is a common occurrence.

The second paper above was prepared by my colleague Grace Filby, BA(Hons), Cert Ed, FRSA – retired deputy Head Teacher. Grace had been making enquiries of the MHRA regarding the length of time girls are ill after vaccination with Cervarix. The MHRA reply was that in their opinion side effects lasted only between 7-10 days. The above paper proves that this information is incorrect. The MHRA reference numbers are identified and this information was obtained from the VAERS reporting system on Cervarix. All of this can be easily checked out per the reference numbers and it will show that there are UK girls who are having more serious side effects which are lasting a longer period of time than is being reported by the MHRA. When you read some of the symptoms in this report you will find that many of them are recognised side effects of this vaccine. The existing MHRA database does not provide any information or reports on the experiences of girls after vaccination with Cervarix. Perhaps for the benefit of the Health Committee, it might be more helpful if you could see in the future what information is actually reported which would give you more of an idea of how the vaccine programme is progressing. At the moment all you get from the MHRA are symptoms and numbers. If there is nothing to hide then there should not be a problem of providing you with fuller reports.

Questions I would wish to raise:

1. Just how safe is aluminium? Aluminium is a recognised neurotoxin and is used as an adjuvant in the vaccine. It has been related to the “Gulf War Syndrome” and a team of scientists also found that vaccination involving aluminium-containing adjuvant could trigger the cascade of immunological events that are associated with autoimmune conditions, including chronic fatigue syndrome and macrophagic myofasciitis, a condition that causes profound weakness and multiple neurological syndromes, one of which closely resembles multiple sclerosis.

2. If HPV strains 16 and 18 are eradicated then is there not a possibility of other HPV cancer related strains becoming more dominant and more virulent? Nature does not normally like a void. If this should occur then this programme will have been wasted. If the vaccine takes out two or three HPV strains, it will give competitive advantage to the rest of them to take over. The same applies with bacteria and antibiotics and there is sufficient evidence of that. Until girls go for their Pap screening then this will not be known but was this possibility ever considered in the first place?

3. Should there not be some screening before vaccination to determine those who are already infected with strains 16 & 18 HPV? If girls are infected with either or both strains then they will not be fully protected or will be unprotected. It has been reported that since the programme of vaccination commenced there has been a rise in the cases of chlamydia in Scottish school girls.

4. Should participants of the HPV programme be informed of all negative aspects as well as the positive aspects of the vaccination programme and should this not take place at time of consent when discussions can take place with their parents?

5. Is sufficient care taken with girls with a history of allergic reactions, serious health issues and on medication prior to vaccination? Cervarix can cause allergic reactions and no trials were carried out to see if there would be a reaction with any types of medication?

6. Are girls sufficiently informed that if they experience an adverse reaction that it should be reported to the Yellow Card System and how many days after vaccination would it be regarded as being caused by the vaccine?

As it has not yet been proved that these vaccines will prevent cervical cancer, we may have to wait up to 30 years to find this out then the responsibility has to rest with those who introduced this programme of vaccination and take on board questions which are relevant as the safety of our school girls is of paramount importance. I hope you will give some time to consider the points I have made above and I thank you in advance. I know girls who have been harmed by both the HPV vaccines and sadly families of girls who have died after Gardasil and therefore that is why I ask for help for there to be more of an investigation into these two vaccines. The information I have provided is all genuine and can be checked out by yourselves – I just believe you are not being given all of the facts and hope that the above provides you with information you were not aware of before. The Cervarix programme covers all girls within the UK.

Yours sincerely

Mrs Freda Birrell – East Lothian

 

Read the response from the Health Department, dated 07 July 2011, here.

Freda Birrell Replies to Health Minister, HPV Vaccine Concerns

26 July 2011, Mrs. Birrell sent the following letter in reply to the Health Minister’s letter:

Dear Minister

My note refers again to your letter of 7th July 2011 and to the fifth paragraph on the first page and I quote:

“There is a possibility that other HPV strains could replace HPV-16 and –18 following the introduction of the HPV vaccination programme. However, there is no data with which to determine whether and how quickly this would take place. The vaccination programme targets the two HPV types that are known to cause the vast majority of cervical cancer to protect the women vaccinated from these established causes of cervical cancer. The Health Protection Agency is carrying out surveillance of HPV types in the population following the introduction of the vaccination campaign to assess the impact of the programme. Women are still encouraged to go for cervical screening when invited.”

I am very concerned by the first two sentences you make above. To start such a crucial and important vaccination programme without taking all the necessary steps to ensure its complete safety is astonishing. I am aware that the Conservatives were not in power when the decisions were made to introduce this vaccination programme to our schools in September 2008. With the history of germs and viruses mutating in the UK, in our hospitals because of mismanagement, overuse, insufficient research having been carried out to determine what effects certain medications/vaccinations would have in the long term, I would have thought greater care would have been taken with a vaccine that only covers two out of the many serious HPV strains which are present at this time – they cover 70% which in itself leaves 30% still vulnerable. It may well be that the two strains targeted, HPV 16 and 18, are the most serious but as our own history dictates that does not mean that others will not become more dominant and more virulent and take over from them if they should be weakened or eliminated. However, for no monitoring to have been carried out prior to this becoming an established programme is quite alarming.

Please see the two letters above, one to Dr Lauri Markowitz, CDC and to Mark Schiffman, Senior Investigator, Maryland. Within these letters, among many other points, is the undernoted which is significant and it would be interesting to know if we have this very advanced form of DNA sequencing available in the UK?

“Based on the VAERS Reports, a significant number of post-vaccinated women are now developing cervical pre-cancer and cancer lesions. It is extremely important for the public to be informed if these cervical pre-cancer or cancer lesions are being caused by vaccine-relevant HPV genotypes or by HPV genotypes not targeted by the HPV vaccines. Since both the FDA [3] and the NCI [4] have acknowledged that the only reliable HPV genotyping is by DNA sequencing, the consumers who have paid a great price for this controversial vaccine want to have post-licensure monitoring data based on HPV genotype determination by DNA sequencing.”

Only by monitoring what happens after vaccination will you be able to determine if the programmes, including both Gardasil and Cervarix, are actually working or if the two strains 16 and 18 are found to be present in some of the subjects, meaning the vaccines have not worked; or other relevant strains are present in the subjects which the vaccines do not cover. Until precise monitoring of data based on HPV genotype determination by DNA sequencing is carried out then you are not going to have any idea what the future holds for all the girls in the UK who have been vaccinated, either with Cervarix or Gardasil. I note you mention that the HPA is carrying out a surveillance of HPV types within the population since this vaccination programme was introduced into the UK. Does that include the young girls aged 12 to 14 who have been vaccinated?; or include the older girls up to the age of 18? We have to bear in mind that Pap screening only begins in Scotland at the age of 20 and in England and Wales at the age of 25.

Therefore, if there has not been, and there is no intention to have, careful monitoring within these younger age groups, then many years will pass before you will have any idea if this programme has been successful or not or if many of these young people have been adversely affected as is now occurring in the States. This could well be a disaster waiting to happen and in your own words ‘you are not in possession of any data to confirm one way or another if other strains are becoming more virulent or if strains HPV 16 and 18 are being eradicated’. Many, many years will have to pass before you will know the answers to this.

Just as an afterthought, because the girls are young does not mean they may not have been infected with HPV prior to vaccination; there is a lot of research carried out by Dr John Cason, King’s College, London whereby he proved that young children can be infected without there having to be any sexual contact. Also another relevant factor and one which also is proven is that there are more cases of Chlamydia in young girls in Scotland (the ages of those being vaccinated) since Cervarix was introduced on to the market. Therefore, many within the relevant age groups are sexually active and sadly it appears they believe the vaccine will protect them from other STD’s which is most definitely not the case. There has been very poor education of the facts.

I now refer you to the reports which are starting to come into the VAERS (Vaccine Adverse Events Reporting System) where the undernoted has been reported. Please remember that these reports cover girls who have been vaccinated with Gardasil and these results are appearing after vaccination has been completed. These numbers represent only between 1% and 10% of affected girls or medical personnel reporting adverse events after vaccination with the HPV vaccine Gardasil. The Gardasil programme started in America in June 2006 – there have to be answers why over a period of five years many of those who were vaccinated are now having the problems that the vaccine was supposed to prevent. This is what I do not wish to see occurring in the UK.

Abnormal Pap Smear 378

Cervical Dysplasia 135

Cervical Cancer cases diagnosed 41 Total = 554

I refer you to our history of overuse of antibiotics and the health conditions which exist with MRSA:

Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium responsible for several difficult-to-treat infections in humans. It may also be called multidrug-resistant Staphylococcus aureus or oxacillin-resistant Staphylococcus aureus (ORSA).

The recent information regarding the dangerous mutation of Gonorrhea

Gonorrhea Dangerous mutation: a disease that had a cure

Posted by Kelley Jeanie On Saturday, July 16th 2011 in News

Gonorrhea is a sexual disease that had a cure if the treatment was based on an antibiotic, but the scientists found that the disease had a dangerous mutation that is very resistant on the cure with antibiotics.

More, the scientist warns that the sexual transmission disease might become a global health problem, especially in this moment when in Japan there was discovered a case of gonorrhea, having the mutation H041, that is incurable. Gonorrhea disease evolved in the last years and all the treatment became one by one inefficient.

These are just two examples of many such incidents which are occurring and which I am sure you will agree are totally alarming. Please consider these points which have been made and realise that I am not just trying to downgrade the vaccination programme but sadly to highlight that insufficient safety measures appear to have been put in place. Can you guarantee that our young girls will not be faced with abnormal Pap smears, Cervical Dysplasia or cases of Cervical Cancer once they are old enough to be screened? Only by being able to give this guarantee will we know that the programme is safe. However, in your own words you honestly cannot do that with the population who have been vaccinated over these last two years and more as there is no data available to determine what is actually going on inside their bodies.

With best wishes

Yours sincerely

Mrs Freda Birrell

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